Modular Tissue Securement Systems

ABSTRACT

A system and method are disclosed for the securement of tissue and in particular for placement of a tongue base suspension fiber for the treatment of obstructive sleep apnea. The system incorporates disposable connectors with releasable needles to facilitate the placement of fibers with minimal increase in suture site dilation or trauma.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention generally relates to systems to secure tissue, moreparticularly to tissue securement systems for treatment of obstructivesleep apnea.

2. Related Art

Obstructive sleep apnea (OSA) is caused by a blockage of the airway,which usually occurs when the soft tissue in the throat collapses andcloses during sleep. According to the National Institutes of Health, OSAaffects more than twelve million Americans. During each apnea event, thebrain briefly arouses the sufferer in order to initiate the resumptionof breathing. This type of sleep, however, is extremely fragmented andof poor quality. When left untreated, OSA may result in high bloodpressure, cardiovascular disease, weight gain, impotency, headaches,memory problems, job impairment, and motor vehicle crashes. Despite theseriousness of OSA, a general lack of awareness among the public andhealthcare professionals results in the vast majority of OSA sufferersremaining undiagnosed and untreated.

In the human body, an air filled space between the nasal cavity and thelarynx is referred to as the upper airway. The most critical part of theupper airway associated with sleep disorders is the pharynx. The pharynxhas three different anatomical levels. The nasopharynx is the upperportion of the pharynx located in the back of the nasal cavity. Theoropharynx is the intermediate portion of the pharynx containing thesoft palate, the epiglottis, and the curve at the back of the tongue.The hypopharynx is the lower portion of the pharynx located below thesoft tissue of the oropharynx. The oropharynx is the section of thepharynx that is most likely to collapse due to the high prevalence ofsoft tissue structure, which leaves less space for airflow. Thehypopharynx lies below the aperture of the larynx and behind the larynx,and extends to the esophagus.

As is well known to those skilled in the art, the soft palate and thetongue are both flexible structures. The soft palate provides a barrierbetween the nasal cavity and the mouth. In many instances, the softpalate is longer than necessary and it extends a significant distancebetween the back of the tongue and the posterior pharyngeal wall.

Although the muscles relax throughout the body during sleep, most of themuscles of the respiratory system remain active. During inhalation, thediaphragm contracts and causes negative pressure to draw air into thenasal cavity and the mouth. The air then flows past the pharynx, throughthe trachea and into the lungs. The negative pressure causes the tissueof the upper airway to deform slightly, which narrows the airwaypassage. In apneic patients, the soft palate, the tongue, and/or theepiglottis collapse against the posterior pharyngeal wall to blockairflow into the trachea. As the airway narrows, airflow through thepharynx becomes turbulent which causes the soft palate to vibrate,generating a sound commonly known as snoring.

During sleep, humans typically experience brief obstructions of airflowand/or small decreases in the amount of airflow into the trachea andlungs. An obstruction of airflow for more than ten seconds is referredto as apnea. A decrease in airflow by more than fifty percent isreferred to as hypopnea. The severity of sleep disorders is measured bythe number of apneas and hypopneas that occur during every hour ofsleep.

If apnea or hypopnea occurs more than five times per hour, most medicalpersonnel diagnose the individual as having an upper airway resistanceproblem. Many of these patients often exhibit symptoms related to sleepdisorders including sleepiness during the day, depression, anddifficulty concentrating.

Individuals having ten or more episodes of apnea or hypopnea duringevery hour of sleep are officially classified as having obstructivesleep apnea syndrome. As the airway is obstructed, the individual makesrepeated attempts to force inhalation. Many of these episodes are silentand are characterized by movements of the abdomen and chest wall as theindividual strains to draw air into the lungs. Typically, episodes ofapnea may last a minute or more. During this time, oxygen levels in theblood will decrease. Ultimately, the obstruction may be overcome by theindividual generating a loud snore or awakening with a choking feeling.

When an individual is awake, the back of the tongue and the soft palatemaintain their shape and tone due to their respective internal muscles.As a result, the airway through the pharynx remains open andunobstructed. During sleep, however, the muscle tone decreases and theposterior surface of the tongue and the soft palate become more flexibleand distensible. Without normal muscle tone to keep their shape and tokeep them in place either alone or as a group, the posterior surface ofthe tongue, the epiglottis, and the soft palate tend to easily collapseto block the airway.

U.S. Pat. No. 7,367,340 describes one approach to treat sleep apnea andis directed to the use of an element that is anchored to the mandibleand is capable of applying force within the tongue to prevent the tonguefrom collapsing during sleep. In the embodiments described, the deviceconsists of an element that is attached to the mandible though drillingof the mandible to provide a rigid point of fixation. The method ofattachment risks damaging the dental anatomy and nerve structures withinthe mandible.

A commercial implant system, sold under the trademark REPOSE™ byInfluENT of Concord, N.H., uses a titanium screw that is inserted intothe posterior aspect of the mandible at the floor of the mouth. A loopof suture is passed through the tongue base and attached to themandibular bone screw. The REPOSE™ procedure achieves a suspension orhammock of the tongue base making it less likely for the base of thetongue to prolapse during sleep. Due to the high activity of the tongueduring wakefulness, however, the suture component of this device may actas a cutting element within the tongue, causing device trans-locationand ultimately a loss of efficacy of the procedure thereby requiringsubsequent removal. Additionally, the fiber is placed within the tonguethrough the combination of a sterile and non-sterile approach. Anincision is made within the sub-mental space to provide access to theinfra-mandibular region to place the screw. Once the screw is attachedto the mandible, the fiber element is passed into the tongue through thesub-mental musculature, through the genioglossus and exits out of themucosal surface of the tongue into the contaminated oral cavity. Thispassage is accomplished through the use of a linear designed suturepasser that grasps the fiber, through the use of a jaw like element, andforces it through the tongue in a straight path. Upon exiting in theoral cavity, the fiber is then passed laterally in a sub mucosal passthrough the original puncture formed by the curved suture passer whichis essentially an eyed needle.

The use of the eyed needle results in the folding of the fiber in halfabout the eyelet of the needle, thereby increasing, in an irregularfashion, the projected diameter/dissecting cross section of the device.This increase in projected dissection surfaces results in the creationof a larger hole than is necessary for the single strand of fiber thatis to be deposited within the tissue tract.

Furthermore, the use of the jawed type linear suture passer also resultsin an increased projected cross sectional dissecting surface. The fiberis laid into the jaw and is clamped. In the best case scenario, the jawresultant projected dissecting tissue surface consists of the crosssectional area of the fiber lying alongside the cross sectional area ofthe shaft of the linear suture passer.

Another commercially available tongue suspension device, developed byASPIRE Medical, is named the ADVANCE System. It's similar to the REPOSEsuture suspension system for the tongue base in that it utilizes a bonescrew in the mandible, but has the advantage of being adjustable. Thedevice utilizes a flexible shape memory anchor within the tongue that isshaped similar to a grappling hook to engage the tissue within thetongue base. It's placed through a small incision in the sub-mentalregion and the suture is attached to a spool-like component attached tothe mandible. Two to four weeks after healing, a small incision is madeunder the chin and a screw is turned to tighten the suture, thus pullingthe device forward. While the device provides a simplified installationtechnique from within the sterile space, the anchors may suffer from ahigh rate of device fracture and failure due to loading within thetongue musculature. Additionally, the risk of damage to the teeth or thenerve roots for the teeth is similar to the RESPOSE bone screw.

In spite of the above advances in tongue suspension devices, thereremains a need for a tongue suspension method and suture passer devicethat enables the passage of fiber with minimal increase in the size ofthe dissected tunnel formed in the traverse of the fiber.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 a-c depict elements of one method of a tissue securement systemparticularly directed toward the threading of fiber through an eyelet ofa linear suture passer and the subsequent passing of the threaded fiberthrough tissue.

FIG. 2 depicts one embodiment of a fiber component of the presentinvention with eyeleted connectors attached to the ends of the fiber.

FIGS. 3 a-3 b show embodiments for a releasably connectable needle andsuture passer suitable for use with the system of the present invention.

FIG. 4 depicts a releasably engaged needle and fiber approaching tissueto be treated.

FIG. 5 shows the releasably engaged needle and fiber penetrating andexiting tissue.

FIG. 6 depicts the releasably engaged needle of FIG. 5 after beingreleased from a securement fiber.

FIG. 7 illustrates use of a fiber passer deployed through themusculature of the tongue to engage connector end of securement fiber.

FIG. 8 shows engagement of a fiber passer with a connector at one of theends of securement fiber prior to pulling of the engaged fiber thoughtissue.

FIG. 9 depicts cutting away of the connectors on the securement fiberends.

SUMMARY OF THE INVENTION

The present invention relates generally to a system for the securementof tissue comprising:

a) a securement fiber comprising a distal end and a proximal end, thedistal end further comprising a distal connector and the proximal endfurther comprising a proximal connector;b) a needle comprising a proximal end and a distal end, the distal endfurther comprising a tissue piercing surface and the proximal endcomprising a connector, the connector being releasably engageable withthe distal connector of the fiber; andc) a tissue passer comprising a proximal end and a distal end, thedistal end releasably engageable with the distal and proximal connectorsof the fiber.

This invention also generally relates to tissue securement methodscomprising the steps of:

a) piercing the tissue at a first puncture point with a needle havingproximal and distal ends that is attached to a securement fiber, thefiber having a first end and a second end with the attachment of theneedle to the fiber occurring at the first end of the fiber and theproximal end of the needle;b) exiting the tissue at a second puncture point with the needle andsecurement fiber;c) releasing the needle from the securement fiber while ensuring thatthe first and second ends of the fiber remain outside of the tissue atthe first and second puncture points;d) passing a fiber passer from a first entry point through the tissueand out of the tissue at the first puncture point;e) attaching the distal tip of the fiber passer with the second end ofthe fiber outside of the tissue at the first puncture point;f) drawing the fiber attached to the fiber passer through the tissue atthe first puncture point by pulling the fiber passer with attached fiberthrough and out of the first entry point;g) releasing the fiber from the fiber passer;h) passing the fiber passer from a second entry point through the tissueand out of the tissue at the second puncture point;i) attaching the distal tip of the fiber passer with the first end ofthe fiber outside of the tissue at the second puncture point;j) drawing the fiber attached to the fiber passer through the tissue atthe second puncture point by pulling the fiber passer with attachedfiber through and out of the second entry point; andk) releasing the fiber from the fiber passer; andl) attaching the fiber ends at the first and second entry points to atleast one anchor or tying the fiber ends together.

In preferred embodiments, the systems and methods of this inventionrelate to securement of the tongue.

The systems and methods of this invention provide at least the followingadvantages. The connector features on the fiber ends enable the use ofreleasable needles, eliminates the need to thread the suture through asnaring/eyed needle type arrangement, and minimizes the tissue tractdiameter for the later passing of the fiber through tissue. The hooktype element on the suture passer allows passes through tissueminimizing the dragging or traumatizing of tissue, permits quickconnection to connector features on the fibers ends, and in combinationwith connector features on the fiber, minimizes the diameter of thetissue tract by ensuring trailing arrangement of the fiber withouthaving the fiber being folded over. The releasable needle enables easyattachment/detachment from the fiber and ensures that the trailingarrangement of the fiber without folding over the fiber to minimize thediameter of the fiber tract through the tissue.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION

The present invention relates to a tissue securement system that is ableto be placed with minimal tissue trauma. The system consists of threekey functional components. The system includes a suspension fiber thathas modified ends, a releasable needle, and a linear suture passer. Thereleasable needle and linear suture passer are designed to engage withthe modified ends of the suspension fiber.

As used herein, the terms “suture” and “fiber” may be usedinterchangeably. Additionally, the terms “suture passer”, “fiber passer”and “tissue passer” are intended to be used interchangeably.

FIGS. 1 a-1 c illustrate a suspension system for securement of tissue 10(in this case a tongue) that consists of unmodified fiber 20 and suturepasser 30. The suture passer 30 illustrated comprises a tapered tip rodwith an eyelet. In use, fiber 20 is manually threaded through the eyeletof suture passer 30 within the oral cavity as shown in FIG. 1 a. FIG. 1b depicts fiber 20 as it begins to be drawn by suture passer 30 throughtissue 10. FIG. 1 c is a cross sectional view of FIG. 1 b and shows analternate view of the path that fiber 20 will take as suture passer 30is drawn through tissue 10. It can be appreciated that within thelimited volume of the oral cavity, that the threading of the fiberrequires dexterity and patience since the motion of the suture passer islimited. Additionally, it can be seen that the fiber is folded in halfabout the eyelet thereby increasing the total cross sectional area ofthe device as it is pulled into the tissue which is a cause foradditional trauma as the doubled over fiber is pulled through thetissue.

FIG. 2 illustrates an embodiment of fiber component 20 of the tissuesecurement system with eyeleted connectors 22 attached. Connectors 22may be attached to fiber 20 by any conventional way including, but notlimited to, crimping the connector to the fiber or by applying anadhesive to the connector and/or the fiber. While eyeleted connectors 22are shown, one skilled in the art would appreciate that alternativeconnectors may be used that involve geometries that engage with thereleasable needle and suture passer. Non-limiting examples ofalternative connectors include conical barbs, flat barbs, male detents,hook-like features, magnetic, or magnetic combined with alignmentfeatures such as conical ends and receptor geometries.

While the connectors 22 may be added as separate elements affixed to theends of the fiber as described above, it would be appreciated by thoseof skill in the art that connectors 22 may be created at the ends of thefiber directly through any number of means, including but not limitedto: i) forming eyelets at the ends of the fiber by bending back an endof the fiber and knotting the fiber end with the fiber to form aneyelet, or, in the case of a multifilament fiber, bending back an end ofa multifilament fiber and then splicing the end into and among thefilaments of the fiber at a distance sufficient from the end of thefiber to form an eyelet; ii) reshaping the fiber ends through mechanicalmeans such as machining, cutting, bending, etc. or iii) shaping thefiber ends into appropriate geometries through the use of energy basedforming such as RF tipping, thermal compression molding, ultrasonicforming and other such methods. For example, in the case ofthermoplastic resin based fibers, it may desirable to form the tip ofthe fiber into a conical barb form or eyelet form for engagement withthe suture passer. The free end of the fiber is placed within a formingdie cavity that is shaped to the final desired geometry. As pressure isapplied to the fiber, the thermoplastic resin exceeds the melting pointof the material and is reshaped to the final cavity form. The fiber issubsequently removed from the form after sufficient time has occurredfor cooling of the fiber material below its melting point. In the caseof thermoset resins, or other non-formable materials, the fiber may beproduced as an oversized form. The fiber may then be placed intostamping die that is capable punching out the final form of the fiberwith the associated connector end geometry.

Examples of suitable materials for fiber 20 component useful with thisinvention are any non-absorbable biocompatible suture material. Suitablenon-absorbable materials for use in the present invention include, butare not limited to, cotton, linen, silk, polyamides (polyhexamethyleneadipamide (nylon 66), polyhexamethylene sebacamide (nylon 610),polycapramide (nylon 6), polydodecanamide (nylon 12) andpolyhexamethylene isophthalamide (nylon 61) copolymers and blendsthereof), polyesters (e.g. polyethylene terephthalate, polybutylterephthalate, copolymers and blends thereof), fluoropolymers (e.g.polytetrafluoroethylene and polyvinylidene fluoride) Poly(hexafluoropropylene-VDF), polyaryletherketones, polyolefins (e.g.polypropylene including isotactic and syndiotactic polypropylene andblends thereof, as well as, blends composed predominately of isotacticor syndiotactic polypropylene blended with heterotactic polypropyleneand/or polyethylene (such as is described in U.S. Pat. No. 4,557,264issued Dec. 10, 1985, assigned to Ethicon, Inc., hereby incorporated byreference in its entirety) and combinations thereof.

In the event that a temporary suspension is desirable, such as in thecase of trauma, or radical surgical interventions that may causeswelling of the tongue and associated tissues, or in other locationssuch as urethra suspension, absorbable fibers may be desirable toprovide temporary support until edema/swelling has been reduced.Suitable absorbable materials for use as filaments and/or yarns include,but are not limited to, aliphatic polyesters which include but are notlimited to homopolymers and copolymers of lactide (which includes lacticacid d-,l- and meso lactide), glycolide (including glycolic acid),ε-caprolactone, p-dioxanone (1,4-dioxan-2-one), trimethylene carbonate(1,3-dioxan-2-one), alkyl derivatives of trimethylene carbonate,δ-valerolactone, β-butyrolactone, γ-butyrolactone, ε-decalactone,hydroxybutyrate, hydroxyvalerate, 1,4-dioxepan-2-one (including itsdimer 1,5,8,12-tetraoxacyclotetradecane-7,14-dione), 1,5-dioxepan-2-one,6,6-dimethyl-1,4-dioxan-2-one and polymer blends thereof.

FIGS. 3 a and 3 b show preferred embodiments in which curved needle 40and linear suture passer 30 are releasably engageable with fiber 20having eyelet connectors 22. More specifically, FIG. 3 a depicts theoverall shape of curved needle 40 with an enlarged view of needle 40'sproximal end, which in this embodiment is shown to comprise a recessedarea with a detent 42 for releasable engagement with eyelet connectors.Similarly, as depicted in FIG. 3 b, suture passer 30 is shown with anenlarged view of its distal tip. Suture passer 30's distal tip comprisesa tissue piercing point and a recessed portion comprising a detent 32.When used with fiber 20 having eyelet connectors 22, the detent 32 ofsuture passer 30 will releasably engage connectors 22 and therefore becapable of drawing fiber 20 through tissue.

Non-limiting examples of suture passer tip designs that may be utilizedwith the previously disclosed fiber connector ends include conicalbarbs, flat barbs for joining with fibers having eyeleted ends, femaledetent pockets, eyelets, hook-like features, quick connect type sleevearrangements, vacuum wells/surfaces, jaw features, passive magnetictips, energy based magnetic tips, or magnetic combined with alignmentfeatures such as conical ends and receptor geometries.

In use, the system of this invention is capable of securing varioustypes of tissue while minimizing trauma to the tissue compared withtissue securement systems of the prior art.

The tissue securement method using the system of this invention isillustrated in the following figures. While the following method isdescribed for securement of a tongue in a tongue suspension procedure,it should be appreciated by one of skill in the art that the methoddescribed is equally applicable to securement or suspension of othertypes of tissue.

Referring to FIG. 4, the tongue suspension procedure is initiated bytargeting an area of the tongue to be treated. In this case, lateralpassage of the suspension fiber is targeted through the tongue at alocation approximately aligned with the median sulcus/circumvallatepapillae and is projected to pass through the mucosal surface of thetongue through the use of the releasable needle 40. FIG. 4 illustratesan approach to this surface of the tongue. Specifically, releasableneedle 40 engaged with fiber 20 by connector 22, approaches tongue 10.

FIG. 5 shows the path of needle 40 through tongue 10. Needle 40 createstwo punctures (P₁ and P₂) by entering tongue 10 approximately 1 cmlateral to the midline position (P₁) and exiting approximately 1 cmlateral on the opposite side of the midline position (P₂). In thisembodiment, the proximal connector 22 of fiber 20 is not pulled throughand remains outside of tongue 10.

FIG. 6 depicts release of needle 40 from fiber connector 22. Oncereleased, fiber 20 is now ready for further steps to secure submucosaltissue of tongue 10 with proximal and distal connectors 22.

FIG. 7 shows a cross sectional view of a portion of human head 50 and afurther step in practicing the method of this invention. Morespecifically, fiber passer 30 is passed from within submental incision52 through the mylohyoid and genioglossus of tongue 10 to an exit pointlocated within the same puncture P₁ created by one of the ends of fiber20. Referring now to FIG. 8, one of the connector ends 22 of fiber 20 isengaged with the engagement element 32 on the end of the fiber passer30. In this embodiment, engagement element 32 is in the form of a hookedrecess at the tip of fiber passer 30. Once element 32 is engaged withfiber 20, the fiber passer 30 is withdrawn to pull the free end ofsuspension fiber 20 into puncture P₁ of tongue 10, through the tongue'smusculature and out of submental incision 52. This step is repeated forthe second end of the fiber 20 through puncture P₂. It is important tonote that the free ends of the suspension fiber 20 may be pulleddirectly through an anchoring element, either rigid or non-rigid,located in the submental dissection 52 or alternatively they maythreaded through the anchor after disengagement with fiber passer 30.

Subsequently, once both ends of fiber 20 are pulled through themusculature and out of submental incision 52, the connector ends 22 arecut off or removed as depicted in FIG. 9.

Once the connectors 22 have been removed, tension is applied to the freeends of fiber 20 to apply the appropriate suspension of the tongue. Thefree ends of fiber 20 may either be tied to themselves, tied to at leastone anchor or may be engaged with a clamping/clipping structure. Commonanchoring points for the free ends of fiber 20 include but are notlimited to bone or soft tissue. In the case of tongue suspensions,anchoring to the mandible bone such done in the REPOSE and ADVANCEanchoring systems are contemplated. Also anchoring at least one end ofthe fiber to mesh implanted in soft tissue is contemplated.

It should be understood that the foregoing disclosure and description ofthe present invention are illustrative and explanatory thereof andvarious changes in the size, shape and materials as well as in thedescription of the preferred embodiment may be made without departingfrom the spirit of the invention.

1. A system for the securement of tissue comprising: a) a fibercomprising a distal end and a proximal end, the distal end furthercomprising a distal connector and the proximal end further comprising aproximal connector; b) a needle comprising a proximal end and a distalend, the distal end further comprising a tissue piercing surface and theproximal end comprising a connector, the connector being releasablyengageable with the distal connector of the fiber; and c) a tissuepasser comprising a proximal end and a distal end, the distal endreleasably engageable with the distal and proximal connectors of thefiber.
 2. The system of claim 1, wherein distal or proximal connectorsof the fiber is selected form the group of connectors consisting of aneyelet, a barb, a hook and a male detent.
 3. The system of claim 2,wherein the connectors of the fiber is a conical barb or a flat barb. 4.The system of claim 1, wherein the connector of the needle is selectedfrom the group consisting of an eyelet, a barb, a hook and a maledetent.
 5. The system of claim 4, wherein the barb is a conical barb orflat barb.
 6. The system of claim 1, wherein the distal end of thetissue passer comprises a geometry selected form the group consisting ofan eyelet, a barb, a hook, and a male detent.
 7. The system of claim 1,wherein the distal and proximal fiber connectors are eyelets, theproximal end of the needle and the distal end of the tissue passercomprises male detents releasably engageable with the eyelets of thefiber.
 8. The system of claim 7, wherein the distal end of the tissuepasser comprises a barb releasably engageable with the eyelets of thefiber.
 9. The system of claim 7, wherein the distal end of the tissuepasser comprises a hook releasably engageable with the eyelets of thefiber.
 10. (canceled)
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 21. The system of claim 1, wherein thefiber is a multifilament fiber.
 22. The system of claim 1, wherein thedistal or proximal connectors of the fiber is selected from the group ofconnectors consisting of flat barbs, conical barbs and magnets.
 23. Thesystem of claim 1, wherein one or both of the distal or proximalconnectors of the fiber are eyelets formed by bending back an end of thefiber and knotting the end of the fiber to form the eyelet.
 24. Thesystem of claim 21, wherein one or both of the distal or proximalconnectors of the multifilament fiber are eyelets formed by bending backan end of the multifilament fiber and splicing the end into and amongthe filaments of the fiber at a distance sufficient from the end of thefiber to form the eyelet.